Urinary tumor
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years (inclusive), gender is not limited; 2. ECOG score 0-2; 3. Patients with urinary tract tumors confirmed by histopathology or cytology; 4. At least one measurable tumor lesion according to RECIST v1.1. Confirmed by CT or MRI at the baseline screening period, the long diameter of the lesion is >= 10 mm (the short diameter of the lymph node lesion is >=15 mm), and the lesion is suitable for repeated and accurate measurement according to RECIST v1.1; 5. Prepare to receive a treatment regimen containing PD-1 inhibitors; 6. Able to eat normally; 7. Agree and be able to cooperate with taking uncontaminated fecal specimens and peripheral blood specimens as required by the program.
Exclusion criteria
Exclusion criteria: 1. Patients judged by the investigator to be inappropriate to participate; 2. Severe internal organ dysfunction and myocardial infarction within the last 6 months; 3. Active, known or suspected autoimmune diseases (such as uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism); 4. Continued use within 10mg/day prednisone or equivalent dose) or other immunosuppressive agents. Inhaled or topical steroids and adrenal replacement steroids are permitted; 5. Known mental illness, alcoholism, drug addiction or drug abuse, etc., which affects informed consent and/or adverse reaction expression or observation; 6. HBsAg positive and HBV DNA detection value exceeds the upper limit of normal (1000 copies/ml or 500IU/ml), or HCV positive (HCV RNA or HCV antibody detection indicates acute and chronic infection). 7. Those who are known to have a history of allergy to the drug components of this regimen; 8. Women who are pregnant or breastfeeding, and women of childbearing age who refuse to accept contraceptive measures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Countries
China
Contacts
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology